Feasibility Trial of Narrative Exposure Therapy (NET) for Posttraumatic Stress Disorder (PTSD) During Pregnancy
NCT04525469 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2022-07-22
Summary
Posttraumatic stress disorder (PTSD) affects up to 35% of pregnant trauma survivors. Moreover, prenatal PTSD rates are up to 4 times higher among communities of color compared to white populations. PTSD during pregnancy has been linked to an increased risk of adverse perinatal and infant health outcomes and may even contribute to racial disparities in adverse perinatal outcomes. Although front-line treatments exist for PTSD, treatment research that specifically focus on pregnancy are extremely limited. Clinical studies examining the safety, acceptability, feasibility, and efficacy of treatments for PTSD during pregnancy are virtually non-existent. Thus, pregnant individuals with PTSD, particularly within low-income communities of color, are a vulnerable and underserved group in need of effective treatment approaches for their distress. Investigators propose to conduct a feasibility and acceptability study of a PTSD treatment, Narrative Exposure Therapy (NET), in a sample of pregnant individuals with PTSD in which low-income people of color are highly represented.
Aim 1: The purpose of Aim 1 will be to examine feasibility. Investigators will evaluate the recruitment and assessment procedures.
Aim 2: The purpose of Aim 2 will be to examine acceptability. Investigators will evaluate participant feedback of the NET intervention.
Aim 3: The purpose of Aim 3 will be to examine the proportion of participants demonstrating clinically meaningful reduction in PTSD and perinatal depression symptoms from pre- to post-treatment.
Investigators will aim to enroll up to 30 participants; participation will last up to ten months. Data sources will include questionnaires, electronic medical records, and qualitative feedback interviews.
With this study, investigators aim to fill a critical gap in knowledge of how to safely and effectively treat PTSD among a vulnerable and underserved population (i.e., perinatal individuals of color).
Conditions
- Post Traumatic Stress Disorder
Interventions
- BEHAVIORAL
-
Narrative Exposure Therapy
NET involves: 1) diagnostic interview and psychoeducation, 2) laying out the Lifeline, 3) NET therapy sessions (constructing the trauma narrative in context of the life course), 4) final session rituals. Laying out the Lifeline (using rope or string) allows participants to take a bird's eye view of the events of their life using simple items such as flowers to represent positive events and stones to represent traumatic events. The focus of NET sessions is to encourage participants to describe the details of traumas and integrating the "cold" memories (i.e., facts) with the "hot" memories (e.g., cognitions, emotions, physiological feelings, and sensory information). The therapist makes notes after each session narrating the details of the traumas ("stones") and reads this at the beginning of each subsequent session. Final session rituals involve re-reading the trauma narrative, hopes for the future, and laying out the final Lifeline placing flowers for hopes and wishes for the future.
Sponsors & Collaborators
-
Rush University Medical Center
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-02-27
- Primary Completion
- 2022-05-01
- Completion
- 2022-05-01
Countries
- United States
Study Locations
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